NA 314.119Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10886982188564), received between Mar 16, 2017 and Sep 25, 2026 — classified as 2 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (28 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device-Device Incompatibility

  It was reported that the screwdriver part arrived from the warehouse already mounted on the T-handle, leaving no option to attach it to the motor for quick removal. The doctor attempted to remove the part from the handle without success, unable to use it on the motor.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897917 ↗
• MalfunctionSep 15, 2026Crack; Material Twisted/Bent; Illegible Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780283 ↗
• MalfunctionJan 22, 2026Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE AO FITTING ON THE SCREWDRIVER SHAFTS ARE ALL DAMAGED AND PROVED DIFFICULT TO LOAD INTO THE AO COUPLING, ON OUT TORQUE LIMITER AND THE POWER TOOL BEING USED BY THE SURGICAL TEAM. THE DRILL BITS WORKED FINE IN BOTH COUPLINGS. THIS PROBABLY ADDED A 7 MINUTE DELAY TO THE CASE WHEN THEY WERE UNABLE TO REMOVE THE SHAFT FROM THE POWER TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147534 ↗
• MalfunctionMay 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIPS OF THE DRIVERS ON T25 STAR DRIVERS HAVE ROUNDED AND WILL NO LONGER PROPERLY SECURE THE SCREW. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS NOTED AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113741 ↗
• MalfunctionMay 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIPS OF THE DRIVERS ON T25 STAR DRIVERS HAVE ROUNDED AND WILL NO LONGER PROPERLY SECURE THE SCREW. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS NOTED AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113740 ↗
• MalfunctionMay 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIPS OF THE DRIVERS ON T25 STAR DRIVERS HAVE ROUNDED AND WILL NO LONGER PROPERLY SECURE THE SCREW. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS NOTED AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113737 ↗
• MalfunctionFeb 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP INSPECTION REVEALED THAT SEVERAL SCREWDRIVERS WERE STRIPPED AND NEEDED REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21378746 ↗
• MalfunctionJan 31, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SCREWDRIVER HEADS ARE STRIPPED. THEY DO NOT ENGAGE SCREW HEADS PROPERLY ANYMORE. THE REPLACEMENT SCREWDRIVER WAS USED TO PROCEED WITH THE PROCEDURE. THERE WAS A TWO MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285341 ↗
• MalfunctionJan 27, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CSPD. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245398 ↗
• MalfunctionJan 27, 2025Material Discolored; Material Twisted/Bent; Material Discolored; Material Twisted/Bent

  IT WAS REPORTED THAT DURING POST OP INSPECTION, ITEMS WERE STRIPPED AND DISCOLORED FROM WASH OF CSPD. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21244902 ↗
• MalfunctionJul 2, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE SURGERY, THE SCREWDRIVER SHAFTS WERE WORN AND NOT ENGAGING WELL IN THE SCREW RECESS. THERE WAS NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19659801 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A SDDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610313 ↗
• MalfunctionJun 25, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE THREADED LOCKING TOWER HAS LOST THE ABILITY TO LOCK INTO THE PLATE. SALES REPRESENTATIVE NOTICED WHILE RESETTING THE TRAYS. THE T25 DRIVER SHAFT WAS ROUNDED OFF ON THE TIP OF THE DRIVER. IT APPEARED WORN DOWN DURING INSPECTION OF TRAYS. SCREWDRIVER SHAFTS AND CONNECTING SCREWS; THE RETAINING PORTION OF THE SCREW HAS WIDENED. THE CONNECTION SCREW WILL NOT RETAIN TO THE SCREWDRIVER ANYMORE. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A SDDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610310 ↗
• MalfunctionJun 17, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT T25 FROM VA LARGE FRAGMENT SETS NEED REPLACING DUE TO WEAR & TEAR. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554545 ↗
• MalfunctionJun 17, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT T25 FROM VA LARGE FRAGMENT SETS NEED REPLACING DUE TO WEAR & TEAR. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554541 ↗
• MalfunctionMay 17, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCRUB NURSE INFORMED THE STERILIZATION TEAM THAT THERE WAS DAMAGE TO THE GUIDE SLEEVE. THE DRILL DOES NOT PASS SMOOTHLY THROUGH THE ITEM ANY LONGER. THE AO COUPLING END HAS DEFORMED AND NO LONGER SITS INTO AN AO COUPLING PROPERLY AND BECOMES JAMMED. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19342602 ↗
• MalfunctionFeb 28, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN BELGIUM AS FOLLOWS: IT WAS REPORTED THAT INTRAOPERATIVELY THE SCREWDRIVER SHAFT COULDN'T BE CONNECTED WITH THE AO COUPLING ON (B)(6) 2024. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18802918 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123050 ↗
• MalfunctionSep 20, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THE TIP OF THE SCREWDRIVER HAS WORN OUT. THIS REPORT INVOLVES ONE (1) STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783315 ↗
• MalfunctionSep 19, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON UNKNOWN DATE THAT THE TIP OF THE SCREW DRIVER HAS WORN OUT. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) SCRDRIVER SHAFT 4.5/5 T25 SELF-HOLDING F. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17774307 ↗
• MalfunctionSep 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THE AO COUPLING GOT STUCK IN THE DRILL AND WOULDN¿T PULL OUT.

  Patient problems: Insufficient Information

  MAUDE report 17728666 ↗
• MalfunctionJul 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE ATTEMPTING TO PUT IN A LOCKING SCREW, THE TORQUE LIMITER WOULD NOT CONNECT TO THE NON-SYNTHES DRILL ATTACHMENT FOR THE SURGEON TO INSERT ON POWER. IT WAS UNCLEAR IF THE TORQUE LIMITER HAD ISSUES, OR THE QUICK CONNECT FOR THE NON-SYNTHES DEVICE WASN¿T WORKING PROPERLY. ADDITIONALLY, THE TIP OF A T-25 SCREWDRIVER WAS ROUNDED OFF AND RISKED STRIPPING THE HEADS OF THE SCREWS BECAUSE IT DID NOT SEAT PROPERLY. THE SCREWS WERE HAND-TIGHTENED AT THE END OF THE CASE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406939 ↗
• MalfunctionJul 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO SCREWDRIVER SHAFTS WOULD NOT CONNECT SMOOTHLY INTO THEIR AO CHUCKS ON THE DRILL/TORQUE LIMITER. THE AO CHUCKS CONNECTED WITH OTHER DEVICES AS EXPECTED. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265550 ↗
• MalfunctionJul 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TWO SCREWDRIVER SHAFTS WOULD NOT CONNECT SMOOTHLY INTO THEIR AO CHUCKS ON THE DRILL/TORQUE LIMITER. THE AO CHUCKS CONNECTED WITH OTHER DEVICES AS EXPECTED. THIS REPORT IS FOR A STARDRIVE SCREWDRIVER SHAFT T25/QC. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265540 ↗
• MalfunctionJan 23, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT THE DEVICE RUPTURE. IT WAS AFFIRMED THE DEVICE ARE WORN OUT . NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16225385 ↗